UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054834 |
|---|---|
| Receipt number | R000062658 |
| Scientific Title | Effect of Gastroesophageal Reflux Disease (GERD) in Esophageal Cancer |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/07/01 15:09:41 |
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Basic information
Public title
Effect of Gastroesophageal Reflux Disease (GERD) in Esophageal Cancer
Acronym
Effect of Gastroesophageal Reflux Disease (GERD) in Esophageal Cancer
Scientific Title
Effect of Gastroesophageal Reflux Disease (GERD) in Esophageal Cancer
Scientific Title:Acronym
Effect of Gastroesophageal Reflux Disease (GERD) in Esophageal Cancer
Region
| Japan |
Condition
Condition
Patients with esophageal cancer and gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of GERD in patients with esophageal cancer by performing a detailed pathophysiological evaluation using non-esophageal cancer patients who have previously undergone esophageal pH and impedance testing and esophageal intra-esophageal pressure testing as controls.
Basic objectives2
Others
Basic objectives -Others
Assessment of Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of gastroesophageal reflux disease.
Factors to be considered: Questionnaire (presence or absence of gastroesophageal reflux symptoms), esophageal pH and impedance testing (Acid exposure time [AET], reflux frequency [acid, weak acid, alkaline reflux], post-reflux swallow-induced peristaltic wave [PSPW] index, baseline impedance value [MNBI], proximal extent frequency, DeMeester score, acid clearance time, Bolus clearance time), esophageal manometry (presence of esophageal motility disorders [EMDs], IRP value, DCI value EGJ type, EGJ-CI value)
Key secondary outcomes
Factors affecting esophageal cancer.
Factors to be considered: patient background (age, gender, BMI, drinking history, smoking history, presence of flasher, family history, presence of H. pylori infection), endoscopy (grade classification by Lugol's spray, presence of atrophic gastritis, Hill grade, presence of hiatal hernia), blood test (ALDH2)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The applicant must satisfy all of the following 1) to 3).
1) Patients who have undergone esophageal pH/impedance test, esophageal endopressure test, and endoscopy at the Department of Gastroenterology, Chiba University Hospital.
2) Patients who have been diagnosed with esophageal cancer (adenocarcinoma or squamous cell carcinoma).
3) Patients who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding.
Key exclusion criteria
1) Those who have expressed their refusal to participate in this research through the information disclosure document
2) Other persons deemed unsuitable by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Ozaki |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
Homepage URL
ozaki.tomomi@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
Tel
43222717
ozaki.tomomi@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062658
